1. Field of the Invention
The invention relates to an integrated analytical system which includes a remote analyzing instrument and a central monitoring station.
2. Description of the Prior Art
Dramatic improvements in industrial productivity and quality have been achieved with the application of computer related technology. Against this backdrop hospitals and hospital laboratories across the country have integrated computers into the hospital care system. Health care traditionally has been a difficult marketplace for automation because of the complexity of the procedures and the potential risks to human life if an error were to occur.
In confronting increasing pressure to reduce the cost of providing analytical results, many laboratories have centralized their services to conserve resources. By consolidating services, expensive equipment has less idle time and labor is used more cost effectively. However, centralization may adversely affect the sample-to-result turnaround time by increasing the distance of the centralized laboratory from the origin of the specimen. Frequently, analytical results must be obtained in a short time to provide information for rapid assessment of a situation so that corrective actions may be taken. In medical care, for example, the clinical state of a critically ill patient must be assessed and corrected before a life threatening condition occurs. Similarly, in the outpatient clinic, providing results of blood analysis to physicians while patients are still in the physicians' office is highly desirable because it obviates the need for a return appointment to discuss abnormal laboratory results. In industrial process control, real-time monitoring of the progress of chemical reactions by on-site analytical techniques prevents dangerous conditions or loss of products.
Up to now, improvements in the turnaround of results have been obtained either by dedicated rapid specimen transportation systems or by simplifications of analytical techniques that make the specimen analysis faster. Pneumatic tube systems, mobile carts, and human messengers have been used with some success to transport specimens rapidly to the central laboratory. However, these systems are expensive to install and maintain; and in some facilities retrofitting of pneumatic tube systems or cart systems is not possible.
Additionally, there has been much interest in simplifying analytical instruments so that non-technical employees can perform complex analysis. For example, physician's office laboratories have been equipped with a new generation of analyzers that can provide rapid results with minimal operator training. Unfortunately, the results provided by many of these simple analyzers are not as precise or accurate as the results obtained in the centralized laboratories. Furthermore, the adequacy of quality control has frequently been overlooked. New pending federal regulations require that only trained medical technologists perform laboratory tests. These regulations will prohibit the physician or paramedical personnel (e.g. nurse or respiratory therapist) from performing clinical laboratory tests.
A user interface indicates a software design that makes many of the complex codes for computerized instrument control and data input/output transparent to the user. Simple English language commands should be used to give instructions to a computer, analytical instrument and/or robot. Although many companies have developed simple-to-use computer, instrument and robotic-control languages accessible to most computer programmers, unfortunately the programming associated with communication with other devices remains incomplete.
Nationally, there has been an increasing trend toward performance of selected laboratory tests using whole blood analyzers located close to the critical care patient's bedside. This approach has the advantage of providing an average test turnaround time of 5 minutes. Up to now, this testing generally has been performed by individuals with minimal training in medical technology. Newly instituted Joint Commission of the American Hospitals Organization and College of American Pathologists ancillary testing regulations require a similar level of quality control as that required by larger laboratories offering similar services. Because most personnel working in intensive care settings have neither the experience nor desire to perform rigorous quality control, this function will be assumed by trained medical technologists from the clinical laboratory in many centers. Staffing these satellite whole blood analysis laboratories with medical technologists will result in much higher costs unless an automated alternative can be developed.
Remote technology could also find a use in laboratories peripheral to the medical center. The estimated 100,000 physicians office laboratories in the United States perform approximately 25% of total laboratory testing. Besides being profitable for physicians, the major incentive for performing laboratory tests in the physicians office is the rapid turnaround. Rapid analysis results in prompt initiation of treatment, reduction in patient stress, and a reduction in repeat office visits. The major criticism of physician office testing is the lack of adequate quality control. Proposed regulations recently issued by the Health Care Finance Administration (HCFA) to carry out the Clinical Laboratory Improvement Act of 1988 (CLIA) require each physicians' office laboratory to monitor and document quality assurance, proficiency testing, safety, and instrument maintenance. Employees must meet the qualifications set forth by the Department of Health and Human Services and be involved in a continuing education program. Robotics can provide many physicians with the laboratory services they require on site yet put the responsibility of monitoring quality, hiring and training qualified personnel, and maintaining instruments in the hands of a local commercial laboratory or hospital. Connection of the remote laboratory in the physicians office to the commercial laboratory could be through a telephone line.
Additional uses can be in the field of microbiology, as many microbiology tests have been reduced to simple devices which can be easily handled by robot. The remote laboratory can be configured to also include microbiology analysis.
The next major medical frontier is the use of molecular biology for identification and diagnosis of genetic-based diseases. Once the aberrant gene is identified, gene therapy eventually may allow replacement of defective genes. Molecular biology is already providing many new tests which are being used to identify various genetic diseases (e.g., cystic fibrosis and sickle cell anemia). There has been a rapid expansion in the number and variety and simplicity of analysis based on genetic markers. The remote laboratory can be used for rapid, on site testing based on molecular biology.
Hematology analysis are usually performed on heparinized whole blood specimens. The heparin (usually in the specimen tube before the blood is drawn into it) serves as an anticoagulant so that the blood remains free flowing. Hematologists are usually concerned with analysis such as white blood cell concentration, the number of subpopulations of white cells, red cell concentration and morphology gradients, and platelet concentrations.
U.S. Pat. No. 4,670,219, Nelson et al, discloses an analysis system having a first region in which sample materials are stored at an appropriate storage temperature and an analysis region which is maintained at a controlled and stabilized temperature higher than the temperature of the first region. The transfer mechanism includes a liquid handling probe that is mounted on a probe transport carriage, and a drive for moving the transport carriage between the first and second regions. The transport carriage includes a storage chamber connected to the liquid handling probe, thermal energy supplying means in heat exchange relation with the storage chamber, and thermal sensor means carried by the transport carriage. Means responsive to the thermal sensor supplies thermal energy to the transport carriage to maintain the storage chamber at substantially the same temperature as the analysis region.
U.S. Pat. No. 4,676,951, Armes et al, discloses an automatic system for analyzing specimens which have been selectively treated. The specimens are arranged in a plurality of specimen trays with each tray containing a plurality of specimens. A work station selectively moves the trays one at a time from the tower to selectively deliver reagent or analyze the specimen in the tray. A control system is adapted to sequentially actuate the work station to properly sequence the system so that the reagents are administered to the respective specimens and the specimens have been analyzed after a desired incubating period.
U.S. Pat. No. 4,781,891, Galle et al, discloses an automatic analyzing apparatus for effecting chemical analysis for various sample liquids such as blood, urine and the like, comprising a sample delivery pump for metering a sample liquid into a reaction cuvette, a reagent delivery pump for delivering to the reaction cuvette a given amount of a given reagent selected from a plurality of reagents contained in a reagent cassette, to form a test liquid, a feed mechanism for successively supplying reaction cuvettes along a circular reaction line, a plurality of photometering sections arranged along the reaction line for effecting a plurality of measurements for each test liquid at different time instances to product a plurality of results.
A major difficulty facing implementors of remote analytical stations in health care is the lack of electronic communications, software, or hardware standards in clinical instruments. Many clinical laboratory analyzers, for example, operate as discreet devices with only a RS-232C port for the output of analytical data. Remote, computerized operation of instruments requires an electronic communication standard that allows many of the instrument electronic functions be accessible to the host computer. For example, an analyzer which has been internally programmed to self-calibrate on a predetermined schedule should not initiate a calibration cycle at the same time as an irreplaceable medical specimen is being injected into the sampling port.
Point of care testing is an important component of caring for the critically ill patient. Rapid assessment of oxygen delivery, acid bases status, electrolytes and glucose are essential. Options for providing these services are rapid delivery of specimens to a central facility using a pneumatic tube system, staffing a satellite laboratory, or having on-site instrumentation. The first two approaches are extremely expensive. The third is a viable option but requires the application of new technologies such as "hand-held" analyzers. The expense of these devices is considerable being in the range of $10 per specimen analysis.
The laboratory disclosed herein is an alternative model to the large centralized laboratory facility. One of the major disadvantages of centralized laboratory facilities is the extended length of time to obtain analytical results. Long turnaround time can result in compromised patient care, particularly in intensive care units. A high cost specimen transportation system has been the traditional method to reduce specimen transit time.
The problems outlined above have been overcome through the instant invention which serves as an alternative to the centralized laboratory by providing analytical services near to where the specimen is obtained without substantially increasing the need for additional labor. The instant invention consists of a method to control commercially available analytical instruments via a computer interface linked to novel computer software. The analytical, electronic and mechanical performance of the laboratory is monitored remotely through electronic, radio or optical link. The automated remote laboratory provides extremely rapid turnaround, eliminates the cost of labor for specimen processing, reduces the risk from contaminated specimens, reduces staff training and results in improved patient care.